Humeral nail having a bracket

ABSTRACT

A humeral nail device for fixing proximal humerus fractures and rotator cuff tears. The humeral nail device includes a flexible proximal humerus nail adapted to be inserted into a humerus and a fixation bracket attached to the nail adapted to repair soft tissue injuries.

SPONSORED RESEARCH OR DEVELOPMENT

The present invention was not developed with the use of any FederalFunds, but was developed independently by the inventors.

BACKGROUND 1. Field

The present invention relates generally to the field of humeral nailtechnologies, and more specifically to a humeral nail for fixingproximal humerus fractures and having a bracket for fixing rotator cufftears.

2. Background

Proximal humeral fractures and rotator cuff tears typically occurtogether at increasing rates. Age, the mechanism of injury, anddislocations at the time of injury are all risk factors for soft tissuedisruption around the bone, such as rotator cuff tears, that may bepresent with fractures of the humerus in the same region.

There exist devices and techniques that can fix humeral fracture, bothproximal ones and fractures in the shaft. There are even ways to fix thesoft tissue and hold it in place while bone healing takes place.However, there is currently no intramedullary implant or implant systemthat can accomplish all of the injury patterns utilizing the same set ofimplants. Current systems require basically two different surgeries, oneto fix the bone and another to fix the soft tissue. This adds time tothe case, and it adds additional set ups (sterile cases and increasedset up time for the operation). The use of one system/implant can helpstreamline both the operative time and the operative set up.

As a general surgical rule, any advance either by technique or byimplants that can simplify complex suturing techniques and still performclinically can be a significant advantage. The technique and implants ofthe present invention can accomplish this by holding the sutures thatrepair soft tissue to the implant. Fewer holes are needed in the bone topass the suture through. This reduces the trauma to the alreadyfractured bone. In addition, the use of flexible nails permit smallerincisions. Using an attached bracket also helps reduce the incision, byallowing sutures to be tied and fixed to one central point.

Thus, a need exists for a humeral nail device, that in the same systemof implants can provide for humeral fracture proximal fixation, humeralfracture shaft fixation, and soft tissue repair of rotator cuff tears.The nail of the present invention is intended to be employed forfixation of both proximal humeral fractures (around the shoulder), andfractures of the humeral shaft (the tube part of the arm bone).Additionally, the nail can aid in repair of the soft tissue around aproximal humeral fracture (such as a rotator cuff tear). This nail canalso be employed when trauma to the shoulder includes both proximalhumerus fractures (around the shoulder) and rotator cuff tears. Thispresent invention solves three humeral injury patterns (proximal humeralfractures, humeral shaft fractures, and proximal humeral fractures thatalso require rotator cuff repairs). The invention includes thecombination of at least three unique designs: a flexible nail for fixingproximal humeral fractures, a humeral shaft fracture nail that controlsfixation distally without cross locking and an intramedullary naildevices that can also fix rotator cuff tears.

SUMMARY

A humeral nail device for fixing proximal humerus fractures and rotatorcuff tears. The humeral nail device includes a flexible proximal humerusnail adapted to be inserted into a humerus and a fixation bracketattached to the nail adapted to repair soft tissue injuries. Theflexible nail may comprise an elongated unitary or integral cannulatedbody having a head portion, a distal tip portion, and an angledfrustoconical intermediate body portion that connects the head portionto the distal tip portion. The fixation bracket may comprise a topplanar leg and an inclined lateral leg connected thereto, a plurality ofsuture holes are provided in the lateral leg. A plurality of screwreceiving openings may be located along the length of the nail head.And, the nail may be made from a titanium alloy, or stainless steel, orcarbon fiber, material.

A connector may be provided between a lower surface of the top leg andan end of the nail head, wherein the nail head is secured to thefixation bracket. The connector may be dovetailed.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments will be described in detail with reference to thefollowing drawings in which like reference numerals refer to likeelements wherein:

FIG. 1 is a front isometric view of a humeral nail device in accordancewith the present invention.

FIG. 2 is a front view of the humeral nail device of FIG. 1.

FIG. 3 is a side view of the humeral nail device of FIG. 1.

FIG. 4 is a rear isometric view of the humeral nail device of FIG. 1.

FIG. 5 is a top view of the humeral nail device of FIG. 1.

FIG. 6 is an exploded isometric view of the humeral nail device of FIG.1.

FIG. 7 is a side view of the humeral nail device of FIG. 1 in use.

FIG. 8 is a front view of the humeral nail device of FIG. 1 in use.

FIG. 9 is a side view of the humeral nail device of FIG. 1 in use.

DETAILED DESCRIPTION

FIGS. 1-6 show a humeral nail device 10 for fixing proximal humerusfractures and rotator cuff tears in accordance with a preferredembodiment of the present invention. The nail device 10 includes aflexible proximal humerus nail 12 and an attached fixation bracket 14.

The humeral nail device 10 is intended for metaphyseal (proximal)humeral fractures with or without soft tissue rupture and injury. Inaddition, the humeral nail device 10 is also intended to be used fordiaphysel (shaft) fractures as well.

Referring now to FIGS. 7-9, the humeral nail device 10 device includes aflexible intramedullary nail 12 for insertion into a humerus 100. Thenail 12 takes form of an elongated unitary or integral cannulated bodyhaving a head 16, an angled frustocontical intermediate body portion 18,and a distal tip portion 20.

As shown in FIGS. 1-7, the nail 12 is inserted into the medullary canalof the humerus 100 to a position in which head 16 is in the proximalregion 102 of the humerus 100, and the distal tip 20 is in the distalregion 104 of the humerus 100. The head 16 is preferably cannulated orhollow along its length in order to provide an axial opening 22 whichextends through the head 16. It is contemplated that the nail 12 beprovided in three lengths of from approximately 240 mm to approximately300 mm. The lengths will cover the sizes necessary to fix most humerussizes. The nail 12 is inserted into the humerus 100 to a position inwhich the top end of the head 16 is adjacent to or, preferably, flushwith, the entry opening formed in the humerus 100.

The humeral nail device 10 also provides a way to incorporate softtissue injuries, such as rotator cuff tears into the repair with the useof the fixation bracket 14. The fixation bracket includes a topgenerally planar leg 32 and an inclined lateral leg 34 connectedthereto. A plurality of suture holes 36 are provided in the lateral leg34 as described in detail below. A connection 40 is provided in thelower surface 36 of the top leg 32 and the end 24 of the nail head 16.The connection preferable takes the form of a partial annulus 42 and acomplementary shaped cylindrical tip 44 of the end of the head 16.Preferably, each complementary part 42 and 44 of the connection 40 isdovetailed as shown to secure the bracket 14 to the nail 12. In thisway, the fixation bracket 14 can be easily fixed or secured to the topof the nail 12 prior to implantation and that enables soft tissue to beanchored securely to the healing bone.

An opening 50 is also provided through the top leg of the bracketcoincident with the connection 40 and the axial opening 22 of the nail12 which acts as a securing arrangement to secure the head 16 of thenail 12 to a device or a tool used for inserting the nail into themedullar canal. Several screw receiving openings 52 are located alongthe length of the nail head 16. The holes are 4 mm in diameter to acceptcancellous bone screws. The holes are offset 5 degrees from each other.This is a common practice in screw and plate design. Screws that areplaced in a straight line may propagate a fracture of worsen an existingfracture. Also offsetting the holes will allow for a wider purchase inthe humeral head. The opening to receive screws 60 proximally isthreaded and is about 3.5 to about 3.75 mm in diameter. And are adaptedto receive the screws 60.

For fractures of the proximal region of the humerus, the medullary canalof the humerus is reamed with an appropriate tool or device according toconventional methods and procedures. The nail is inserted into the canalusing conventional methods and appropriate tools and devices, includingguiding devices, such as guiding wires. Following the insertion of thenail into the medullary canal, the screws are inserted through the boneand into the openings. For fractures of proximal humerus, the screws areinserted into the proximal openings.

The humeral nail device 10 combines the flexible nail 12 with proximalfixation screws 16. The humeral nail device 10 combines ease ofinsertion without the need for distally cross locking.

The flexibility of the nail 12 permits the nail 12 to become settleddistally in the humerus 100. One preferred material to provide therequisite strength and flexibility is a titanium alloy, which would addto the flexibility of the nail. The proximal fixation implant 10 alsoprovides a way to incorporate soft tissue injuries, such as rotator cufftears into the repair with the use of the fixation tab 14. The fixationtab 14 can be easily fixed or secured to the top of the nail 12 prior toimplantation and that enables soft tissue to be anchored securely to thehealing bone.

The screws 16 are inserted through the nail 12 in the proximal portionwith the aid of a targeting guide (not shown) and provide proximalfixation.

The nail 12 is an intramedullary device for humeral fractures. It istypically placed thru a small incision just above the top lateral cornerof the humerus 100, using either an awl (not shown) or placed directlythrough an existing fracture fragment. An insertion tool (not shown) isused to place the nail 12 into the humerus 100 and helps guide the nail12 into place.

The length of the nail 12 is chosen by the surgeon and is determinedprior to surgery. The 12 nail is seated into the distal humerus eitherby hand or with the use of a mallet.

This nail system treats proximal humerus fractures (close to theshoulder joint), fractures in the shaft of the humerus, and proximalhumeral fractures that also have soft tissue injuries such as a rotatorcuff tear.

The nail 12 fixes a proximal humeral fracture with cross locking screws60. The screws 60 are inserted with the use of an external guide. Thescrews 60 pass through the nail 12 and hold the fracture fragmentstogether. The screws 60 are oriented at different angles, to improve theholding power in weak bone.

Typically, the nail 12 locks only proximally. Length and rotationalcontrol is maintained by driving the nail into distal metaphyseal bone(by the elbow). Also the nail 12 can be inserted into the intramedullarycanal of the humerus without reaming the diaphysel bone. If there is noadditional step of reaming the canal, surgical time is reduced.

Although embodiments have been described with reference to a number ofillustrative embodiments thereof, it should be understood that numerousother modifications and embodiments can be devised by those skilled inthe art that will fall within the spirit and scope of the principles ofthis disclosure. More particularly, various variations and modificationsare possible in the component parts and/or arrangements of the subjectcombination arrangement within the scope of the disclosure, the drawingsand the appended claims. In addition to variations and modifications inthe component parts and/or arrangements, alternative uses will also beapparent to those skilled in the art.

1. A humeral nail device for fixing proximal humerus fractures androtator cuff tears, comprising a flexible proximal humerus nail adaptedto be inserted into a humerus, and a fixation bracket attached to thenail adapted to enable soft tissue to be anchored securely to thehumerus.
 2. The humeral nail device in accordance with claim 1 whereinthe flexible nail comprises an elongated unitary or integral body havinga cylindrical head portion adapted to be inserted into the medullarycanal of the humerus and sized such that the head portion is adjacent anentry opening in the humerus when so inserted, a distal tip portion, andan angled frustoconical intermediate body portion that connects the headportion to the distal tip portion such that the distal tip portion is atan acute angle relative to a centerline of the head portion. 3.(canceled)
 4. The humeral nail device in accordance with claim 1 whereinthe fixation bracket comprises a top planar leg and an inclined lateralleg connected thereto, a plurality of suture holes are provided in thelateral leg.
 5. The humeral nail device in accordance with claim 2wherein the fixation bracket comprises a top planar leg plate and aninclined lateral planar leg plate connected thereto and extending at anacute inclined angle relative to the top leg plate back towards the headportion, a plurality of suture holes are provided in the lateral legsized to accommodate a suture therein to secure soft tissue.
 6. Thehumeral nail device in accordance with claim 4 wherein a connector isprovided between a lower surface of the top leg and an end wall of ahead portion of the nail such that the lower surface of the top legabuts the end wall of the head portion, the end wall being perpendicularto the longitudinal centerline of the head portion wherein the headportion is secured to the fixation bracket.
 7. The humeral nail devicein accordance with claim 5 wherein a connector is provided between alower surface of the top leg and an end wall of a head portion of thenail such that the lower surface of the top leg abuts the end wall ofthe head portion, the end wall being perpendicular to the longitudinalcenterline of the head portion, wherein the head portion is secured tothe fixation bracket.
 8. The humeral nail device in accordance withclaim 6 wherein the connector is a circular dovetailed connection. 9.The humeral nail device in accordance with claim 7 wherein the connectoris a circular dovetailed connection.
 10. (canceled)
 11. The humeral naildevice in accordance with claim 2 wherein a plurality of screw receivingopenings are located along the length of the head portion, and arepositioned to be adjacent the metaphyseal portion of the humerus tosecure the screws into the metaphyseal portion.
 12. The humeral naildevice in accordance with claim 4 wherein a plurality of screw receivingopenings are located along the length of the head portion, and arepositioned to be adjacent the metaphyseal portion of the humerus tosecure the screws into the metaphyseal portion.
 13. (canceled) 14.(canceled)
 15. The humeral nail device in accordance with claim 2wherein the nail is made from a titanium alloy material.
 16. A humeralnail device to fix proximal humerus fractures and rotator cuff tears,comprising a flexible intramedullary humerus nail adapted to be insertedinto a medullary canal of a humerus, the nail having an elongatedcylindrical distal tip body and a cylindrical proximal head portion, alongitudinal axis of the elongated body being at an acute angle relativeto a longitudinal axis of the head portion, the elongated body beingsized such that a top of the head portion is substantially flush with anentry opening in the humerus when the nail is inserted into themedullary canal during use, and a fixation bracket attached via aconnector to the had portion, the bracket having rows of holes having adiameter substantially the same size as a diameter of a suture and sizedto accept a sutures therein to enable soft tissue to be anchoredsecurely to the humerus during use, the fixation bracket having a topplate and a lateral plate extending therefrom at an acute angle backtowards the elongated body of the nail, the connector having a firstpart extending outwardly from a top end wall of the head portion and acomplementary second part formed in the top plate.
 17. The humeral naildevice in accordance with claim 16 wherein one of the first and secondparts being a partial annulus and the other of the first and secondparts being a complementary extending tip.
 18. The humeral nail devicein accordance with claim 17 wherein the connector being a circulardovetailed connection
 19. The humeral nail device in accordance withclaim 17 wherein the nail has a frustoconical intermediate portionconnecting the distal tip portion and the head portion, a longitudinalaxis of the intermediate portion being coincident with the longitudinalaxis of the distal tip.
 20. The humeral nail device in accordance withclaim 19 wherein a plurality of screw receiving openings are locatedalong the length of the head portion, the screw opening being radiallyoffset by at least 5 degrees from each other, the screw openings arepositioned to be adjacent an epiphyseal portion of the humerus to securescrews into the epiphyseal portion.
 21. The humeral nail device inaccordance with claim 20 wherein the top plate has a tool openingcoincident with the connector opening to receive an insertion tooltherein.
 22. The humeral nail device in accordance with claim 21 whereinthe nail having a length between 420 mm and 300 mm and the nail is madefrom a titanium alloy material.